In the pooled analysis of the DUET studies at 96 weeks, 57
percent of patients in the INTELENCE arm had an undetectable viral
load (<50 copies>

"These data are important because they add to the body of
knowledge on INTELENCE, an important option for
treatment-experienced patients with NNRTI and PI resistance," said
DUET clinical investigator Tony Mills, MD, HIV specialist in
private practice, Los Angeles, and Assistant Professor of Clinical
Medicine, UCLA.

When it received accelerated approval by the U.S. Food and Drug
Administration (FDA) in January 2008, INTELENCE was the first NNRTI
to be introduced in nearly ten years. Since then, INTELENCE has
been approved in nearly 50 countries. In January 2009, an
application was submitted to the FDA for traditional approval,
which included 48-week data from DUET-1 and DUET-2. The FDA will
need to determine if these data are sufficient to support
traditional approval.

When it received accelerated approval by the U.S. Food and Drug
Administration (FDA) in January 2008, INTELENCE was the first NNRTI
to be introduced in nearly ten years. Since then, INTELENCE has
been approved in nearly 50 countries. In January 2009, an
application was submitted to the FDA for traditional approval,
which included 48-week data from DUET-1 and DUET-2.

INTELENCE, in combination with other antiretroviral (ARV)
agents, is indicated for the treatment of human immunodeficiency
virus type 1 (HIV-1) infection in antiretroviral
treatment-experienced adult patients who have evidence of viral
replication and HIV-1 strains resistant to a NNRTI and other ARV
agents.

This indication is based on Week 24 analyses from two
randomized, double-blind, placebo-controlled trials of INTELENCE.
Both studies were conducted in clinically advanced, three-class
antiretroviral (NNRTI, N[t]RTI, PI) treatment-experienced
adults.

The following points should be considered when initiating
therapy with INTELENCE:

-- Treatment history and, when available, resistance testing, should
guide the use of INTELENCE.
-- The use of other active antiretroviral agents with INTELENCE is
associated with an increased likelihood of treatment response.
-- In patients who have experienced virologic failure on an
NNRTI-containing regimen, do not use INTELENCE in combination with
only N[t]RTIs.
-- The risks and benefits of INTELENCE have not been established in
pediatric patients or in treatment-naive adults.
DUET-1 and -2 Study Design

The DUET-1 and -2 studies, identical in design and conducted
across the Americas, Australia, Canada, Europe, Thailand and
Europe, assessed the 24-week efficacy and safety of INTELENCE in
combination with a BR in treatment-experienced adult HIV-1 patients
with documented evidence of NNRTI and PI resistance. They were
large randomized, controlled studies and the primary endpoint was
the proportion of patients who achieved a confirmed undetectable
viral load (less than 50 copies/mL).

Patients with HIV-1 who were eligible for the DUET trials had a
viral load of greater than 5,000 copies/mL, were on a stable
antiretroviral therapy regimen, and had evidence of at least one
NNRTI-resistance-associated mutation, either at screening or from
historical resistance tests as well as evidence of three or more
primary PI mutations (D30N, V32I, L33F, M46I/L, I47A/V, G48V,
I50L/V, V82A/F/L/S/T, I84V, N88S, or L90M) at screening.

Participants in the DUET studies were randomized to receive
INTELENCE 200 mg twice daily (599 patients) or placebo (604
patients), each given in addition to a BR. For all patients, the BR
included darunavir/ritonavir, plus at least two
investigator-selected antiretroviral drugs (N(t)RTIs with or
without enfuvirtide).

The study was designed to evaluate INTELENCE efficacy and safety
over 48 weeks with an optional extension to 96 weeks. The study
remained double-blinded until the last study participant reached
week 48.

DUET-1 and -2: 96-Week Efficacy Data

The 96-week pooled analysis of the DUET studies showed the
following efficacy results:

-- Fifty-seven percent of patients in the INTELENCE arm had an
undetectable viral load (<50 copies>

INTELENCE does not cure HIV infection or AIDS, and does not
prevent passing HIV to others.

Warnings & Precautions
-- Severe Skin Reactions: Severe and potentially life-threatening skin
reactions, including Stevens-Johnson Syndrome, hypersensitivity
reaction, and erythema multiforme, have occurred (<0.1%) in patients
taking INTELENCE. Treatment with INTELENCE should be discontinued and
appropriate therapy initiated if severe rash develops. In general, in
clinical trials, rash was mild to moderate, occurred primarily in the
second week of therapy, and was infrequent after Week 4. Rash
generally resolved within 1-2 weeks on continued therapy.
Discontinuation rate due to rash was 2%.
-- Fat Redistribution: Redistribution and/or accumulation of body fat
have been observed in patients receiving antiretroviral (ARV) therapy.
The causal relationship, mechanism, and long-term consequences of
these events have not been established.
-- Immune reconstitution syndrome has been reported in patients treated
with ARV therapy, including INTELENCE.
Use in Specific Populations
-- Hepatic Impairment: INTELENCE should be used with caution in patients
with severe hepatic impairment (Child-Pugh Class C) as
pharmacokinetics of INTELENCE have not been evaluated in these
patients.
Adverse Reactions
-- The most common adverse events (>10%) of any intensity that occurred
at a higher rate than placebo at 24-weeks were rash (16.9% vs. 9.3%)
and nausea (13.9% vs. 11.1%).
-- The most common treatment-emergent adverse reactions (Grade 2-4) that
occurred in patients receiving an INTELENCE-containing regimen vs.
placebo at 24-weeks were rash (9.0% vs. 3.1%), diarrhea (5.2% vs.
9.6%), nausea (4.7% vs. 3.5%), fatigue (3.3% vs. 4.0%), abdominal pain
(3.0% vs. 2.5%), peripheral neuropathy (2.8% vs. 1.8%), hypertension
(2.8% vs. 2.2%), headache (2.7% vs. 4.1%), and vomiting (2.3% vs.
2.0%).
Drug Interactions
-- INTELENCE should not be co-administered with the following ARVs:
tipranavir/ritonavir, fosamprenavir/ritonavir, atazanavir/ritonavir,
full-dose ritonavir (600 mg bid), protease inhibitors administered
without ritonavir, and other NNRTIs.
-- INTELENCE should not be co-administered with carbamazepine,
phenobarbital, phenytoin, rifampin, rifapentine, rifabutin (when part
of a regimen containing protease inhibitor/ritonavir) or products
containing St. John's wort (Hypericum perforatum).
-- INTELENCE and lopinavir/ritonavir should be co-administered with
caution.
-- Co-administration of INTELENCE with other agents such as substrates,
inhibitors, or inducers of CYP3A4, CYP2C9, and/or CYP2C19 may alter
the therapeutic effect or adverse events profile of INTELENCE or the
co-administered drug(s). This is not a complete list of potential drug
interactions.

Please see full Product Information about INTELENCE for more
details. A copy of full Product Information can be obtained by
visiting www.INTELENCE-info.com.

You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088.

About Tibotec Therapeutics

Tibotec Therapeutics, a division of Ortho Biotech Products,
L.P., headquartered in Bridgewater, N.J., is dedicated to
delivering innovative virology therapeutics that help healthcare
professionals address serious unmet needs in people living with
HIV.

About Tibotec Pharmaceuticals

Tibotec Pharmaceuticals, based in Cork, Ireland, is a
pharmaceutical research and development company, with offices in
Yardley, PA, USA and its main research and development operations
in Mechelen, Belgium. Tibotec is dedicated to the discovery and
development of innovative HIV/AIDS drugs and anti-infectives for
diseases of high unmet medical need.

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